MAUDE Adverse Event Report: MALEM MEDICAL MALEM SELECTABLE BEDWETTING ALARM

Model Number ULTIMATE SELECTABLE

Device Problems Leak/Splash (1354); Melted (1385)

Patient Problem Burn, Thermal (2530)

Event Date 06/21/2017

Event Type  Injury  

Event Description

Just received the alarm today.I placed it on my son at night and he went to sleep.Just a few hours ago, my son came to my bedroom and said that his neck was burning.The alarm was sitting on the bed and i noticed that the backing had melted with the batteries leaking out.This is crazy.How can this happen? his neck is burnt from the alarm.I administered first aid and have discontinued using the alarm.

• Brand Name: MALEM SELECTABLE BEDWETTING ALARM
• Type of Device: MALEM SELECTABLE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6666572
• MDR Text Key: 78456079
• Report Number: MW5070599
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE SELECTABLE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR